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Data Review Supervisor
at Vertex
Boston, MA

Data Review Supervisor
at Vertex
Boston, MA

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Description

Job Description:

This role manages the data review function of Release and Stability Laboratory department supporting validation, testing and reporting of in-process, release and stability samples. Specific assigned persons are responsible for the supervision of other RSL personnel, optimizing Department resource allocation according to project/program needs to assure testing activities occur in an efficient and cGMP compliant manner while fostering the Vertex vision and values.


Key Responsibilities:
  • Coordinate laboratory testing review activities to ensure completion in a timely manner.
  • Prioritizes resources appropriately to meet commitments on time.
  • Ensure direct report lab personnel have adequate training, education, and experience to perform their GMP related job function effectively.
  • Provides guidance to direct reports when issues arise
  • Maintains and monitors related data review metrics to identify areas of focus to increase right first time
  • Provides developmental feedback and coaching to direct reports to create a collaborative environment that attracts, develop and retains personnel.
  • Participates in compliance related teams working towards the goal of continuous improvement.
  • Authors and reviews data, SOPs, analytical methods, protocols and reports.
  • May author OOS/OOT investigations and laboratory deviations.

Qualification:

  • A minimum of a Bachelor Degree in science or related discipline is required.
  • 5+ years of experience in pharmaceutical/biopharmaceutical industry with 0-2 years of supervisory responsibility.
  • Basic knowledge of US and EU cGMP regulations/guidance.
  • General knowledge of analytical methodologies such as chromatography, dissolution, and Karl Fisher.
  • Strong attention to detail.
  • Effective communication skills, both verbal and written.

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